Quality Assurance Compliance Manager
Work Location : Fall River, MA
Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)
Reports To : Head of Quality Assurance
Purpose
The QA Compliance Manager is responsible for ensuring that all compliance related activities comply with U.S. regulatory requirements, primarily governed by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing.
Job Responsibilities
- Ensure timely and effective closure of all internal, external, regulatory, and customer audit observations through robust corrective and preventive actions (CAPA).
- Independently prepare, review, and submit Field Alert Reports (FARs) in accordance with FDA regulatory requirements.
- Lead and manage initiation and execution of product recalls at various levels, ensuring regulatory compliance and effective cross-functional coordination.
- Oversee document control operations, ensuring accurate receipt, review, archival, and maintenance of controlled documents in compliance with data integrity and record-keeping requirements.
- Ensure timely submission of document to iron mount.
- Ensure document control room is managed properly and ready for all time audit.
- Maintain continuous inspection readiness for internal, external, and regulatory audits through proactive quality oversight and compliance monitoring.
- Develop, manage, and execute the site internal audit program, including audit scheduling, conduct, reporting, and follow-up activities.
- Identify, investigate, and remediate site-wide data integrity issues to ensure compliance with regulatory expectations and industry best practices.
- Ensure compliance with applicable FDA regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 11 (Electronic Records and Signatures), and 21 CFR Part 820, as applicable.
- Interpret and implement FDA guidance documents, compliance policies, and regulatory expectations across site quality systems.
- Monitor FDA regulatory updates and industry trends to assess impact and ensure ongoing site compliance and operational readiness.
- Serve as the primary Quality Assurance representative and lead during FDA inspections, including Pre-Approval Inspections (PAI), routine surveillance, and for-cause inspections.
- Lead the preparation and submission of responses to FDA Form 483 observations.
- Track and manage site-wide training activities to ensure timely completion and maintain zero overdue or pending training requirements, supporting continuous inspection readiness
- Collaborate closely with Regulatory Affairs and cross-functional stakeholders to align inspection strategies, communication plans, and regulatory responses.
- Review FDA Form 483 observations and ensure implementation of agreed corrective actions across the facility.
- Coordinate cross-functional meetings to drive compliance activities, define action plans, assign responsibilities, and ensure timely completion of commitments and target completion dates (TCDs).
- Review the deviation, CAPA and change request initiated against the audit observation to ensure the observation requirements are met.
- Impart data integrity and GDP related training to new hire during orientation program.
- Investigate and review the market/ product compliant for commercialized product and ensure its onetime closure as per SOP timeline.
- Send the compliant related sample to outside vendor for investigation.
- Any other work assigned by Head Unit Quality Assurance and Site Quality Head.
Educational & Experience:
- Minimum of a bachelor's degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field of study from an accredited institution.
- Minimum of ten (10) years of collective work experience in QA Department, QC lab, preferably in a pharmaceutical manufacturing company preferred.
- Minimum of two (2) years supervisory and team leadership experience, both hourly and salaried staff.
- Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing, and computerized system validation, equipment validation and data integrity.
- Relevant understanding and knowledge about CFR part 11 regulations.
- Preferably have prior MDI experience or in Drug Device combination products.
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